Animal drugs, feeds, and related products: Fenbendazole suspension,
[Federal Register: November 18, 1998 (Volume 63, Number 222)]
[Rules and Regulations]
[Page 63982-63983]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no98-7]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oral Dosage Form New Animal Drugs; Fenbendazole Suspension; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulation concerning veterinary prescription use of Hoechst Roussel Vet's fenbendazole suspension for cattle. The amendment clarifies the oral dose of fenbendazole suspension used as a dewormer in cattle.
EFFECTIVE DATE: November 18, 1998.
FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7575.
SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd., P.O. Box 4915, Warren, NJ 07059, is sponsor of new animal drug application (NADA) 128-620 that provides for oral, veterinary prescription use of Panacur‹Register› (fenbendazole) 10 percent suspension. The drug is used as a dewormer in cattle, including dairy cattle of breeding age at 5 milligrams per kilogram (mg/kg) of body weight, and only in beef cattle at 10 mg/kg of body weight. The regulations are amended in 21 CFR 520.905a to clarify the approval.
The amendments clarify the drug dose used to treat various classes of animals and insert certain technical revisions. No additional safety or effectiveness data were required. A revised freedom
[[Page 63983]]
of information summary is provided to reflect the clarification.
List of Subjects in 21 CFR Part 520
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
The authority citation for 21 CFR part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
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Section 520.905a is amended by removing paragraph (a); by redesignating paragraphs (b) and (c) as paragraphs (a) and (b); by adding paragraph (c); by revising the heading of paragraph (d)(2); by redesignating paragraph (d)(3) as paragraph (d)(4); by redesignating paragraphs (d)(2)(ii), (d)(2)(ii)(A), and (d)(2)(ii)(B) as paragraphs (d)(3)(i), (d)(3)(ii), and (d)(3)(iii); by adding a heading for newly redesignated paragraph (d)(3); by redesignating paragraphs (d)(2)(i)(A) and (d)(2)(i)(B) as paragraphs (d)(2)(ii) and (d)(2)(iii) to read as follows:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(c) Related tolerances. See Sec. 556.275 of this chapter.
(d) * * *
(2) Cattle including dairy cows of breeding age--* * * * * * * *
(3) Beef cattle--* * * * * * * *
Dated: November 9, 1998. Andrew J. Beaulieu, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 98-30750Filed11-17-98; 8:45 am]
BILLING CODE 4160-01-F
